Repetitive Brake Activation

Not Applicable

Completed

• Conditions: Obesity; Ileal Brake; Eating
• Interventions: Other: Ileal infusion of casein; Other: Ileal infusion of tap water

• Registration Number: NCT02511366
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The appearance of intact macronutrients in the small intestine induces an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. Several studies showed that intraileal infusion of nutrients resulted in a reduction in food intake. However only acute effects were investigated in these studies and thus far it is not known whether repetitive (intermittent) infusion results in adaptation to repeated exposure and, thus, a lowered ileal brake response.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-04-09
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-30
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Based on medical history and previous examination, no gastrointestinal complaints can be defined.
• Age between 18 and 65 years. A higher age comes with a higher chance of comorbidities. These could influence our study outcomes and therefore this age range was chosen. Furthermore, we think this study would be too invasive for subjects over the age of 65. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
• BMI between 18 and 25 kg/m2)
• Weight stable over at least the last 6 months (≤5% weight change)

Exclusion Criteria

• History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
• Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
• Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
• Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
• Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
• Pregnancy, lactation
• Excessive alcohol consumption (>20 alcoholic consumptions per week)
• Smoking
• Blood donation within 3 months before the study period
• Self-admitted HIV-positive state
• Evidence of casein or hypersensitivity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ileal infusion of casein	Ileal infusion of casein	Ileal infusion of casein
ileal infusion of tap water	Ileal infusion of tap water	ileal infusion of tap water

Primary Outcome Measures

Name	Time	Method
Ad libitum food intake	1 Day	Ad libitum food intake will be measured in kcal and the end of each test day (4 in total, all within one week)

Secondary Outcome Measures

Name	Time	Method
Satiety	1 Day	Visual analogue scale forms for satiety (0-100 mm scale) wil be filled in during each test day (4 in total, all within one week)
Gastrointestinal peptide release (CCK)	1 Day	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)
Gastrointestinal peptide release (GLP-1)	1 Day	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)
Gastrointestinal peptide release (PYY)	1 Day	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)
Gastrointestinal peptide release (insulin)	1 Day	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)
Gastrointestinal peptide release (glucose)	1 Day	Blood will be drawn during each test day (multiple time points) (4 in total, all within one week)
gastric emptying rate	1 Day	Gastric emptying rate with 13C octanoic acid breath test to determine T1/2
Gallbladder volume	1 Day	Gallbladder measurements with ultrasound (volume of GB in mL will be scored)
Small intestinal transit time	1 Day	Small intestinal transit time measurements with H2 breath analyser and lactulose

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands